Excerpted from CCHR’s submission to the FDA opposing its 2015 proposal to reclassify the ECT device as a Class II low risk device. CCHR’s submission was submitted in March 2016.
The Food and Drug Administration (FDA) Proposal in 2015 to reduce the risk classification of the ECT device instead of banning it, is of enormous concern, because of potential conflicts of interest of those it is relying upon.
A majority of those psychiatrists in the FDA neurological device advisory committee panel (on ECT devices) hearing held in 2011 that wanted the device rated as a lower risk Class II had conflicts of interest with brain stimulation devices or ECT device companies. Several of these and representatives of the APA argued that it would be too expensive for ECT device manufacturers to conduct clinical trials.
The following comments show that the decision to make the device Class II was likely made before the 2011 Hearing because the major indications for which ECT is to be administered as Class II could not sustain a clinical trial and, as such, APA psychiatrists claim the financial burden shouldn’t be placed on the manufacturers to do so. This is arguably to protect their practices and is not in the interest of patients.
Consider attorney Rick Moxon’s submission to the FDA which stated that in a deposition, the President of ECT device manufacturer, MECTA, admitted the company “does not do research.”[1] Ms. Robin Nicol, originally a salesperson at MECTA, bought MECTA with her husband, Gorham Nicol, and became CEO in 1980. Mr. Nicol said: “The doctors in research centers provide the medical requirements and information we need to build the equipment because our function is strictly as a manufacturer.”[2]
On January 23, 2011, psychiatrist Conrad M. Swartz, co-owner of ECT device maker, Somatics, LLC, was reported in The New York Times as saying that the company could not afford an in-depth study that the FDA could require if it left the devices as Class III. “There is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature,” Dr. Swartz said.[3]
The APA conceded this as far back as 1981, when in April that year, the chairman of the APA’s Council on Research wrote in The American Journal of Psychiatry: “Unless a successful reclassification petition [for Class II] is filed, the manufacturers have until April 4, 1982, to prove safety and efficacy or discontinue production of their devices. There does not appear to be any great move on the part of the manufacturers to accomplish this.”[4]
Furthermore, in 2011, immediately prior to the FDA panel hearings, Dr. Matthew Rudorfer, a psychiatrist who administers and oversees grant money for NIMH, is its associate director for treatment research and head of ECT Research, and appears closely affiliated with research psychiatrists with financial ties to ECT device makers, told The New York Times that clinical trials would be “too expensive” for “mom and pop” operations such as the manufacturers of ECT devices.[5]
- Dr. Rudorfer co-wrote an ECT textbook published in 2003 with Dr. Harold Sackeim, Ph.D., who has received at least $8 million over 20 years from NIMH while having financial ties to and is a consultant to MECTA and Somatics, LLC.[6] In the book Shock Therapy: A History of Electroconvulsive Treatment in Mental Illness, a 1994 photo of an “ECT Victory Party” thrown by Sackeim celebrating the founding of the journal Convulsive Therapy, included Matthew Rudorfer, Max Fink, Charles Kellner and psychiatrist Richard Weiner, a MECTA consultant, who developed ECT devices for the company.[7] Dr. Rudorfer is the co-author of a 2011 study on ECT along with Dr. Charles Kellner claiming ECT’s “unsurpassed efficacy and remarkable safety.” A comment on the ineffectiveness of ECT is that Rudorfer et al redefine ECT’s failure as “ECT-induced remission;” i.e., while there may be apparent changes in mood following the ECT (arguably because of the violence of the shock shifting the person’s attention), this period is disingenuously called a period of remission but to prevent a relapse (because the ECT treatment failed), the authors recommend Continued ECT (C-ECT) for up to 6 months after the first index of ECT treatment, potentially followed by Maintenance ECT (M-ECT) to prevent a new episode.[8] The study cites research conducted by Kellner, Max Fink, Dr. Abrams and Harold Sackeim—all of whom have financial affiliations with ECT device makers.
- Dr. Rudorfer received the Honored Speaker award at the annual meeting of the International Society for ECT and Neurostimulation (ISEN), held during the May 2012 American Psychiatric Association annual meeting.[9] ISEN is the former Association for Convulsive Therapy, the official journal of which is the Convulsive Therapy, edited by ECT-device affiliate, Dr. Max Fink. In 2015, Dr. Rudorfer was quoted admitting: “Very early ECT was basically plugging the brain into the wall socket with electricity available and channeling it to the brain….It was very strong and probably overkill.”[10] But he discounts patients’ major concern of memory loss, claiming, “There are some people who firmly believe that they have experienced permanent memory loss, but it is impossible to assess these statements objectively.”[11] This is an officer of the government discounting the evidence of patients it should be protecting.
- Dr. Sackeim was a member of the APA ECT Task Force in 2001 and, as stated above, he is a consultant to and has received funding from Somatics, LLC and MECTA.[12] MECTA has also funded his ECT studies.[13] In 1981, NIMH began giving Dr. Sackeim grants to study the “affective and cognitive consequences of ECT.”[14] In testimony given to the New York State Assembly investigating ECT on May 18, 2001, it was stated: “Because Sackeim had a lock on this [NIMH] money for 20 years, because his money is renewed automatically for as long as he wants it without his proposals having to compete with other grants, and because he sits on the panel which decides who gets funded, other researchers aren’t able to get grants to do research in this area. Dr. Sackeim is on the American Psychiatric Association’s Task Force on ECT, and he’s the spokesman for industry….While he has been getting millions of NIMH dollars, he’s also been a consultant for, and received grant money from, the companies that make most of the shock machines in America….”[15]
- Richard D. Weiner has a long-standing relationship with MECTA and consulted for SOMATICS, Inc.[16] In the 1978 APA ECT Task Force Report it acknowledges Weiner for his research, while not disclosing that as an engineer he had developed ECT machines for MECTA, wrote their instruction manuals and did a video for them.[17] Circa 1985, he was in charge of the APA’s lobbying campaign at the FDA, while he had conflicts of interest with MECTA and consulted for SOMATICS.[18] In 1995, he filed a patent for an “electroconvulsive therapy method using ictal EEG data as an indicator of ECT seizure adequacy.”[19] He was Chairman of the APA ECT Task Force 1990. In 2005, he was on the Speaker’s Bureau of MECTA.[20] He is a co-inventor on a Duke University-patent licensed to MECTA but says he receives no royalties for the patent.[21] Dr. Weiner chaired the APA’s ECT Task Force in 2001 and was a member in the 2010 Task Force.
- Max Fink was part of the first APA ECT Task Force in 1978 and was an author of its report. He served on the APA’s 1990 ECT task force, which drafted guidelines for the treatment. He has made videos about ECT for SOMATICS, Inc. which paid him $18,000 for the rights to the videotapes.[22] In 1997, he was a principal investigator in a multicenter collaborative study group known as CORE (Consortium for Research in ECT) under grants from NIMH, along with Charles Kellner.[23]
- Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) and responsible for the premarket approval of all medical devices, as well as overseeing the safety, effectiveness and quality of them, is married to a prominent lawyer, Allison Shuren, from Arnold & Porter LLP. The law firm’s clients include “pharmaceutical, medical device and biotechnology companies.’’ Allison Shuren co-heads the FDA/Healthcare group in the company.[24] The company represented the founders of The Lieber Institute for Brain Development in its formation and establishment and in subsequent collaborations. The Lieber Institute is the only institution entirely dedicated to research on psychiatric disorders.[25] In February 2015, The Lieber Institute won a grand prize for helping to further the understanding of how electroconvulsive therapy works to relieve depression.[26] The Institute has also funded ECT studies.[27]
- In February 2011, Public Citizen wrote Dr. Shuren strongly urging FDA to maintain the classification of ECT devices as class III given the serious risks that these devices present: “FDA should require that—within a reasonable but specified time frame—rigorous, ethically justifiable clinical trials be conducted to evaluate the safety and effectiveness of ECT devices for their current indications for use, and that data from such trials be submitted to FDA for review and evaluation under a Premarket Approval Application (PMA). Further premarket studies, both pre-clinical (bench, animal) and clinical, also should be required for any significant changes in ECT device technology or proposed new indications for use.”[28]
In 1994, Douglas G. Cameron addressed ECT conflicts of interest in the Journal of Mind and Behavior, stating: “An insidious source of misinformation about ECT’s effects on memory are videotapes marketed by some of the ECT device manufacturers (Somatics, LLC, MECTA) and made available to patients, family members, and shock facility professionals in the United States and Canada. There are no disclosures in these videos identifying either Somatics, LLC or MECTA as manufacturers of ECT device….”[29]
References:
[1] Deposition from civil case Atze Akkerman vs MECTA, cited in submission to the FDA, 16 Jan. 2011, p. 7.
[2] Rick Moxon’s statement to FDA Hearing; Linda Andre, Doctors of Deception: What They Don’t Want You to Know about Shock Treatment, (Rutgers University Press, 2009) p. 194.
[3] Duff Wilson, “F.D.A. Is Studying the Risk of Electroshock Devices,” The New York Times, 23 Jan. 2011, http://www.nytimes.com/2011/01/24/business/24shock.html?_r=1&pagewanted=print.
[4] Linda Andre, Doctors of Deception: What They Don’t Want You to Know about Shock Treatment, (Rutgers University Press, 2009) p. 148, citing J.M, Davis, “Official Actions: The Council of Research,” American Journal of Psychiatry, 138 (4), 1981, p. 572.
[5] “F.D.A. is Studying the Risk of Electroshock Devices,” The New York Times, 23 Jan. 2011, http://www.nytimes.com/2011/01/24/business/24shock.html; Susan FitzGerald, “Despite Protests, Shock Treatment Gains New Respect,” Philly.com (Philadelphia Inquirer), 17. Oct. 1998, http://articles.philly.com/1988-10-17/news/26272212_1_ect-mental-patient-harold-sackeim.
[6] Op. cit., Linda Andre, pp.192-196.
[7] Ibid. p. 239.
[8] http://www.karger.com/article/pdf/328943
[9] http://www.dcpsych.org/pdfs/currentnews.php
[10] https://www.mcleanhospital.org/sites/default/files/shared/News_Assets/Politico.Dukakis.9315.pdf
[11] https://www.washingtonpost.com/archive/lifestyle/wellness/1985/06/05/second-opinion-the-lifesaving-side-of-shock-therapy/99b37fd2-c584-48fe-9068-ee7b51f0e66c/
[12] Chris Dubey, “A summary of references against electroshock treatment,” Examiner, Nov 21, 2012, http://www.examiner.com/article/a-summary-of-references-against-electroshock-treatment; New York State Assembly Report on Electroconvulsive Therapy (ECT), March 2002, http://assembly.state.ny.us/member_files/125/20020416/.
[13] Comprehensive CV of Sackeim, as published by Clinical Neuropsychiatry Journal of Treatment Evaluation, www.clinicalneuropsychiatry.org/biografie/sackeim.php.
[14] Op. cit., Linda Andre, pp. 195-198.
[15] Testimony of the Director of Committee for Truth in Psychiatry, New York State Assembly, May 18, 2001, http://www.ect.org/news/newyork/andretest.html; Max Fink Interviewed by David Healy, Dec. 8, 2008.
[16] Op. cit., Linda Andre, pp. 198-199.
[17] Electroconvulsive Therapy, ECT Task Force report, (APA) Sept. 1978, pp. iii; Linda Andre, p. 198-199.
[18] Ibid., p. 145, p. 154, p. 161-162.
[19] Ibid., p. 198-199.
[20] Program, American Psychiatric Association 2005 Annual Meeting, Atlanta, GA, May 2005; http://journals.lww.com/ectjournal/Citation/1990/06000/The_1978_and_1990_APA_Task_Force_Reports_.2.aspx.
[21] Mehul Mankad, MD, et al., “Clinical Manual of Electroconvulsive Therapy,” American Psychiatric Publishing, Inc., 2010, http://psychoreanimatology.org/download/books/Clinical_Manual_of_Electroconvulsive_Therapy_2010.pdf.
[22] “ECT Experts’ Ties to Shock Machine Industry,” http://www.ect.org/news/posta.html.
[23] Arline Kaplan, “Through the Times With Max Fink, M.D.,” Psychiatric Times, September 1, 2005, http://www.psychiatrictimes.com/articles/through-times-max-fink-md/page/0/5; Mount Sinai Hospital webpage, http://www.mountsinai.org/profiles/charles-kellner.
[24] http://www.chambersandpartners.com/usa/person/328489/allison-w-shuren
[25] http://www.libd.org/
[26] http://www.libd.org/research-activities/our-news
[27] http://www.brainstimjrnl.com/article/S1935-861X%2815%2900966-3/abstract
[28] Public Citizen, Letter to Jeffrey E. Shuren, M.D., J.D.,
Director, Center for Devices and Radiologic Health, Food and Drug Administration, 24 Feb 2011, http://www.citizen.org/hrg1933
[29] Douglas G. Cameron, “ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation,” The Journal of Mind and Behavior; Winter and Spring 1994, Vol. 15, Nos. 1 and 2; Pages 177-198, http://www.brown.uk.com/brownlibrary/CAMERON.htm.